UnknownNot Applicable

Myocardial Work and Metabolism in CRT

Belgium, Norway200 participantsStarted 2015-09

Plain-language summary

Several attempts have been made to refine selection criteria for cardiac resynchronisation therapy (CRT) in heart failure patients with reduced ejection fraction (HFrEF). Previously proposed parameters probably do not sufficiently reflect the underlying mechanical dyssynchrony of the left ventricle (LV). Earlier work of our research group suggests that better candidate selection can rely on the direct observation or measurement of this LV mechanical dyssynchrony by means of non-invasive imaging. In this study apical rocking and other non-invasive measures of LV mechanical dyssynchrony will be applied to evaluate regional myocardial workload and metabolism, and determine their predictive value in CRT response.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria Subject is eligible for CRT implantation according to current European Society of Cardiology guidelines of 2013. * The patient should receive guideline-directed optimal medical therapy for heart failure and left ventricular (LV) function must be severely depressed (LV ejection fraction ≤35%). * The patients should be in NYHA functional class II, III or ambulatory IV. * The patient should present a left bundle branch block (LBBB) with QRS duration of \>120ms or a non-LBBB with QRS \>150ms. * Also patients with conventional pacemaker in NYHA functional class III and ambulatory IV if high percentage of ventricular pacing, are eligible for CRT implantation. * Subject is in stable sinus rhythm at the time of CRT implant and during the last 2 weeks prior to inclusion. * Subject is 18 years or older and able and willing to consent. Exclusion Criteria: * Impossible to obtain LV volumes by echocardiography. * Right bundle branch block. * Permanent atrial fibrillation, flutter or tachycardia (\>100 bpm). * Recent myocardial infarction, within 40 days prior to enrolment. * Subject underwent coronary artery bypass graft (CABG) or valve surgery, within 90 days. * Post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year. * Implanted with a LV assist device (LVAD), or has reasonable probability (per investigator's discretion) of receiving …

What they're measuring

Cardiac resynchronisation therapy (CRT) response assessed by echocardiography

Timeframe: Change of left ventricular end-systolic volume (LVESV) between baseline and 6 months after CRT implantation

CRT response assessed by echocardiography

Timeframe: Change of LVESV between baseline and 12 months after CRT implantation

Trial details

NCT IDNCT02537782

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12-01

View on ClinicalTrials.gov More Left Ventricular Dyssynchrony trials